Trials / Completed
CompletedNCT02981602
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection
A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Escalation Study to Examine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ISIS 505358 in Treatment-Naïve Patients With Chronic HBV Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection
Detailed description
This study examines the effects of IONIS-HBVRx or placebo (3:1 randomization) administered subcutaneously to treatment-naïve patients who are chronically infected with HBV and the effects of subsequent nucleos(t)ide analogue treatment on these patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IONIS-HBVRx | Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2017-02-24
- Primary completion
- 2019-12-18
- Completion
- 2019-12-26
- First posted
- 2016-12-05
- Last updated
- 2021-08-10
- Results posted
- 2020-12-21
Locations
7 sites across 2 countries: Hong Kong, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02981602. Inclusion in this directory is not an endorsement.